Response to: ‘Comment on: ‘Lupus Low Disease Activity State(LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hocanalysis of the Phase IIb MUSE trial of anifrolumab’ by Eric Morand et al’ by Isenberg

Abstract

The authors thank Professor Isenberg 1 for pointing out a drafting error on the manuscript reporting the use of the Lupus Low Disease Activity State (LLDAS) in the anifrolumab phase II trial data set. 2 The British Isles Lupus Assessment Group(BILAG) instrument does indeed document gastrointestinal disease activity, while Systemic Lupus Erythematosis (SLE) Disease Activity Index 2000 (SLEDAI-2K) does not. This error does not impact on the findings of the published paper, or the intended meaning of the sentence in which this error occurred, which was a discussion of the need for evidence that the physician global assessment adequately captures gastrointestinal activity in SLE.

Pragmatic targets for moderate/severe SLE and their implications for clinical care and trial design: sustained DORIS or LLDAS for at least 6 months is sufficient while their attainment for at least 24 months ensures high specificity for damage-free progression

“…Indeed, in the study by Golder et al, 11 less than 30% of patients had SLE Disease Activity Index 2000 (SLEDAI-2K) ≥6 at inclusion; in this group, LLDAS occurred less frequently as compared with counterparts with SLEDAI-2K <6 (23.6% vs 58.7%, respectively). This trend is also reflective on the low prevalence of LLDAS [19][20][21] and DORIS 22 at week 52 in lupus RCTs, which typically enrol patients with moderate or high disease activity. A closely related matter is that patients with higher degrees of activity/severity tend to receive more glucocorticoids, 23 especially at the early phases of treatment, which could potentially dampen the damage-protective effects of low disease activity or remission states attained later during the disease course.…”

Efficacy and safety of the type I interferon receptor inhibitor anifrolumab in patients with systemic lupus erythematosus (results of a 6-month study)

“…Таким препаратом является анифролумаб (АФМ, Сафнело ® ) -человеческое моноклональное антитело IgG1κ, продуцируемое в клетках миеломы мыши (NS0) с помощью технологии рекомбинантной ДНК, связывающееся с клеточным рецептором для ИФНα (IFNAR1) с высокой аффинностью и специфичностью [17,18]. К настоящему времени в мире проведено четыре рандомизированных клинических исследования эффективности и безопасности АФМ у пациентов с СКВ: MUSE (II фаза) [19], TULIP-1 [20], TULIP-2 [21] и TULIP-LTE (III фаза) [22]. На основании результатов этих исследований АФМ был зарегистрирован для использования у пациентов с умеренной и высокой активностью СКВ.…”

“…Насоновой по программе раннего доступа. «Исследовательская программа по изучению эффективности и безо- [16][17][18][19][20][21][22][23][24] Objective: to evaluate the efficacy and safety of the type I interferon (IFN) receptor inhibitor anifrolumab (AFM, Safnelo ® ) in patients with systemic lupus erythematosus (SLE) in real-life clinical practice over an observation period of 6 months. Material and methods.…”

209 Attainment of low disease activity and remission with atacicept in patients with systemic lupus erythematosus and high disease activity in the phase IIb ADDRESS II study and its long-term extension

“…1 2 Lupus Low Disease Activity State (LLDAS) is associated with reduced damage accrual, 2 and has been shown to be a feasible clinical trial endpoint. 3 In patients with high disease activity (HDA; SLEDAI-2K ≥10) enrolled in the ADDRESS II study, atacicept improved SLE responder index (SRI)-6 response rates and flare prevention at Week 24 vs placebo. Atacicept also demonstrated an acceptable safety profile.…”